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Biostatistical Programming Senior Associate

Amgen

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Location:
India, Hyderabad

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Amgen is expanding its global Statistical Programming capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Senior Associate, you will perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions.

Job Responsibility:

  • Perform hands on statistical programming activities to support complex statistical data analysis of clinical studies and regulatory submissions
  • Analysis and reporting of clinical trial data using SAS and/or R
  • Creation and validation of complex SDTM, ADaM, and other analysis datasets, both safety and efficacy
  • Creation and validation of complex tables, listings, and figures, both safety and efficacy
  • Prepare statistical programming specifications
  • Prepare statistical programming related documents for regulatory submissions
  • Maintain tracking and validation documentation
  • Collaborate with cross-functional team and create and/or validate complex programs for checking data quality
  • Interact and collaborate with study team members from other functions globally
  • Assist in some of the tasks of the Study Lead Programmer (SLP) or serve as a backup SLP

Requirements:

  • BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects
  • At least 4 years of statistical programming experience in a clinical development environment
  • Familiarity with drug development life cycle
  • Excellent skills with the manipulation, analysis and reporting of complex clinical trial data
  • Ability to effectively perform complex statistical programming and related tasks
  • Ability to provide quality output and deliverables in adherence with challenging timelines
  • Ability to work effectively on multiple tasks or projects across therapeutic areas
  • Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
  • Working knowledge of latest CDISC SDTM standards
  • Familiar with CDISC ADaM and Define standards with strong ability to implement the standards
  • In depth knowledge of SAS/STAT packages
  • Familiar with data quality and compliance check tools
  • Excellent oral and written English communication skills

Nice to have:

  • MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
  • Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming
  • Prior regulatory submission experience for drug approval
What we offer:
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging
  • Teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Additional Information:

Job Posted:
December 18, 2025

Work Type:
On-site work
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